Highlighting the Regulatory Pathway & Timelines: Working Towards an IND

Time: 4:30 pm
day: Day Two


  • Understanding ethical challenges of early implementation and overcoming the lack of reliable existing data
  • Allergen stability demonstration challenges over varying lifecycles timepoints and how to obviate these facets
  • Mitigating risk of anaphylaxis at every stage of the clinical trial protocol according to best scientific and empirical practices
  • Navigation of FDA Combination Product Regulatory Categorization in order to ensure comprehensive patient-safety